Abbott Senior Analyst Post Market Surveillance in Burlington, Massachusetts
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Under the direction of the department manager, the Senior Product Surveillance Analyst will perform the same duties as the Product Surveillance Analyst, and depending on their location, may perform both the role of CVD product complaint investigation and returned product analysis. As a Senior Product Surveillance Analyst, they will also be expected to be an information source for the Product Surveillance Department and be able to demonstrate sound independent decision making in regards to global medical device reporting and other functions relating to the investigation of product complaints.
Assisting the department manager in ensuring all global medical device reports are filed within regulatory timeframes
Represents Product Surveillance at cross-functional meetings as requested or in the absence of the department manager
Lead a small team of direct reports.
Provides training on complaint reporting to other groups
Supports Product Surveillance Data Analyst by performing trending
Supports complaint database upgrades, changes, conversions through design input, testing, maintenance functions
Ensures complaint information on intranet sites is maintained
Orders department supplies in accordance with budget
Support inspections by regulatory agencies (e.g. FDA, TUV) as requested
Assists in training new employees and maintaining training documents
Is vigilant of product complaint trends
Ensures department procedures and work instructions are maintained
Supporting and instruct other department members as needed on product complaint investigations and devices
Collaborate independently with other team members and departments needing product complaint information
Act as information resource to other Product Surveillance team members
Be able to conduct investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints
Be able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department management
Use procedures, judgment and experience to determine appropriate testing of returned products with minimal guidance
Perform CAPA investigations as they relate to complaint reporting
Be able to ascertain when additional support may be needed from other teams on complaint investigations (e.g. potential manufacturing-related issues)
Train others in Product Surveillance product complaint handling
Support department manager in their absence
Provide support to Legal Dept on product complaints
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Four-year degree, preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis.
At the senior level, knowledge of global regulations for medical device reporting and complaint handling is a must. Strong written and oral communication skills are required.
2 plus years of experience with CAPA
Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously.
Problem-solving and proficient computer skills are required.
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to provide guidance to a small team of direct reports.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel approximately 5%, including internationally.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org